Olympus Corporation of the Americas: Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomica

Hazard

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

Details from the source

Reason for recall: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW. Quantity: 1158 units Lot/code info: UDI-DI: 00815686020613 Lot Number: 04991210310 and below

UPC codes

00815686020613, 04991210310

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.